Late Acquired Malaposition and Different Polymers

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Late Acquired Stent Malaposition

Treatments: Procedure: Biolimus-Eluting-Stent (BES); Procedure: Everolimus-Eluting Stent (EES); Procedure: Zotarolimus-Eluting-Stent (ZES)

Study type: Interventional

Funder types: Other

Identifiers

NCT02018991

MUW-0001

Details and patient eligibility

About

The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM) with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM in DES with newer-generation polymers designed to improve biocompatibility are unknown.

Full description

please see brief summary

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who underwent an elective treatment of a coronary lesion > 20mm with a DES

Exclusion criteria

• chronic renal failure (serum creatinine ≥ 2.5mg/dl)
• restenotic lesions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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69 participants in 3 patient groups

Everolimus-Eluting-Stent (EES)

Active Comparator group

Description:

Patients treated with EES

Treatment:

Procedure: Everolimus-Eluting Stent (EES)

Zotarolimus-Eluting-Stent (ZES)

Active Comparator group

Description:

Patients treated with ZES

Treatment:

Procedure: Zotarolimus-Eluting-Stent (ZES)

Biolimus-Eluting-Stent (BES)

Active Comparator group

Description:

Patients treated with BES

Treatment:

Procedure: Biolimus-Eluting-Stent (BES)